MAUDE Adverse Event Report: SEASPINE INC. MARINER MIS PEDICLE SCREW SYSTEM CORTICAL SHANK, CANNULATED

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

No implants were made available for review as the hardware remains in-situ. Additionally, the patient is reported to be fused and asymptomatic. The surgeon plans to monitor the patient for any indication prompting surgical intervention; however, it is not believed to be necessary at this time from a clinical standpoint. Review of the x-ray provided confirms the screw fracture reported. Review of labeling: possible adverse events. Bending, disassembly or fracture of implant and components.

Event Description

The patient underwent a 3-level spinal surgery consisting of seaspine's mariner pedicle screw system from level l3-s1. The index surgery date is unknown. Seaspine was made aware on (b)(6) 2020 of a post-operative left s1 screw fracture.

• Brand Name: MARINER MIS PEDICLE SCREW SYSTEM
• Type of Device: CORTICAL SHANK, CANNULATED
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 10908940
• MDR Text Key: 241399833
• Report Number: 3012120772-2020-00089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial